Monthly Archives: May 2016

The Italian Administrative Supreme Court Opens New Perspectives for Therapeutic Equivalents

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By rejecting an appeal from Novartis, the Italian Administrative Supreme Court, with its decision n. 1306 of April 1st, 2016, focused on the notion of therapeutic equivalence under Italian law. Having underlined the difference with the concept of bioequivalence and having broadened its possible future application, the decision is likely to push forward the trend of public health care institutions to increase competition between pharmaceutical companies in the context of public tender offers, possibly for the benefit of taxpayers and patients.

The controversy arose from an opinion issued by the Italian Medicines Agency (“AIFA”) which, in a tender procedure held by Tuscany region, evaluated the drug Lucentis by Novartis (active ingredient ranibizumab) as a therapeutic equivalent to Eylea by Bayer (active ingredient aflibercept). This allowed the regional public administration to have the said drugs compete against each other in the same tender offer.

Debates as to whether Lucentis and Eylea are equivalent in terms of functions are not indeed new in the pharmaceutical scene and have caused many headaches to Novartis, let alone the critical issues raised in relation to Lucentis by the Italian Antitrust Authority.  Not a surprise, then, that Novartis tried to defend its product, alleging the illegitimacy and erroneousness of AIFA’s evaluation, which stated that the cheaper option by Bayer (Euro 780) is equally safe and effective in the treatment of macular degeneration as it is its more expansive (Euro 902) drug.

Novartis, nevertheless, failed in its claims. The Italian Administrative Supreme Court confirmed the validity and correctness of AIFA’s evaluation, together with the decision of the lower court, affirming, inter alia, that:

  • therapeutic equivalence is different from bioequivalence because the latter implies the identity of the active ingredient whether the former does not (indeed, FDA’s indications on the issue are rather similar);
  • the authority of AIFA in determining therapeutic equivalence is legitimate under Italian law;
  • evaluations regarding therapeutic equivalence cannot be based exclusively on the products’ leaflet: they are instead well motivated if they verify that (i) the drugs belong to the same Anatomical Therapeutic Chemical class; (ii) the drugs are subject to a similar route of administration and (iii) the drugs release the active ingredient in comparable ways.

Therapeutic equivalence, as it has recently emerged from Italian legislation and case law (in particular, from the decision discussed herein), is seen as a threat by pharmaceutical companies, unnerved by the increased competition effects.

Indeed, the debate has been escalated to a more general level by the Italian association of pharmaceutical companies, which challenged in many ways AIFA’s guidelines on therapeutic equivalence. As a consequence, a few days ago AIFA precautionary suspended for ninety days the said guidelines.

It looks like the match has just begun. Nevertheless, pharmaceutical companies should consider carefully on which side they should play. In fact, the expansion of the application of therapeutic equivalence, as a general trend, does not seem to be stoppable in a constant spending review context. Perhaps pharmaceutical companies should positively contribute to shape, rather than to stop, therapeutic equivalence and exploit its potential for the business in terms of new opportunities to access tender offer procedures.

FDA’s Initial Thoughts on 3D Printing of Medical Devices Published Today

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Curious about how regulations on 3D printing of medical device will evolve? Check out the draft guidance published today by the United States Food and Drug Administration (“FDA”). Comments and suggestions are welcome and should reach the FDA within the next 60 days.

The draft guidance looks interesting under a number of aspects. First of all, it provides a definition of additive manufacturing (“AM”), i.e., “a process that builds an object by iteratively building 2-dimensional (2D) layers and joining each layer below, allowing device manufacturers to rapidly alter designs without the need for retooling and to create complex devices built as a single piece.”

It also defines itself as a “leap-frog guidance” and clarifies that “leap frog guidances are intended to serve as a mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development”, which is a nice way to say that the FDA recognizes that its thoughts are just initial and subject to change.

A number of caveats are singled out and manufacturers are invited to be careful about, and to design their quality systems so they take due account of:

  • device design, which can be altered in AM due to various factors (pixelation of features, various patient-matching techniques, effects of imaging, etc.)
  • software and software interactions;
  • machine parameters and environmental conditions;
  • material used (which can be raw material or recycled);
  • post-processing phase;
  • process validation and acceptance activities;
  • device testing;
  • cleaning and sterilization;
  • biocompatibility.

The FDA also believes that AM devices that are patient-matched should be subject to additional labelling information.

The draft guidance does not address the use or incorporation of biological, cellular, or tissue-based products in AM, which may require additional regulation. Also, point-of-care device manufacturing may raise additional technical considerations.

Art. 29 Working Party on EU-US Privacy Shield: Trust Not Yet Restored For Transatlantic Data Flows

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Only few months after the 2015 Court of Justice of the European Union (CJEU) landmark decision that put an end to the Safe Harbour system, the EU Commission proudly announced a new framework agreement with the US authorities, allegedly providing strong safeguards, sufficient to “enable Europe and America to restore trust in transatlantic data flows” (Commissioner Věra Jourová).

According to the Commission’s press release, the Privacy Shield’s guarantees include:

  • strong obligations on companies and robust enforcement;
  • clear safeguards and transparency obligations on US government access;
  • a redress possibility through an independent Ombudsperson mechanism;
  • effective protection of EU citizens’ rights through various measures (a specific timeline for resolving complaints , a free of charge alternative dispute resolution solution, as well as the possibility for EU citizens to lodge complaints with their national Data Protection Authorities, who will work with the Federal Trade Commission to solve them).

Nevertheless, the newly issued opinion of the Art. 29 Working Party (“WP29”) already raised strong criticism against the Privacy Shield, tempering the Commission’s enthusiasm. Although WP29 did not abstain from underlining the improvements the Privacy Shield offers in comparison to the invalidated Safe Harbour decision, its concerns seem to eclipse those positive features, leading to the overall negative assessment of the new framework. Moreover, the impression is that the Privacy Shield led to more uncertainty, leaving everyone frustrated, with the exception of those authorities that negotiated it.

But what are, then, according to WP29, the improvements offered by the Privacy Shield? On the other hand, what major concerns does it raise? Finally, does it provide for adequate answers to post-Safe Harbour issues?

Firstly, it must be recognized, as WP29 certainly does, that the Privacy Shield represents a large step forward from Safe Harbour in terms of data protection. And, one could argue, it couldn’t be otherwise, since the Safe Harbour decision dates back sixteen years ago, before Facebook, the social network, big data era and the emergence of encryption vs. surveillance-like debates.

However, WP29 welcomes the additional recourses made available to individuals to exercise their rights, together with the extensive attention dedicated to data accessed for purposes of national security and law enforcement. Increased transparency measures are also appreciated by WP29: both those offered by the US administration on the legislation applicable to intelligence data collection and those provided through the introduction of two Privacy Shield Lists on the US Department of Commerce website (one containing the records of those organizations adhering to the Privacy Shield and one containing the records of those that have adhered in the past, but no longer do so).

Unfortunately, it seems that, these (few), general, positive notes are by far neutralized by the much more incisive negative remarks made by the WP29. WP29 points out the inadequate safeguards set forth to protect some key data protection principles under European law: the data retention principle is not expressly mentioned by Privacy Shield instruments (nor it can be clearly construed from their current wording) and onward transfers of EU personal data to third Countries are insufficiently framed. Despite the EU Commission’s enthusiastic press releases, WP29 underlines how, from the documents signed  by US authorities, it cannot be fully excluded that US administrations will continue the collection of massive and indiscriminate data. And one cannot abstain from noting how crucial the latter aspect is, being one of the main reasons that led the CJEU to invalidate the Safe Harbour decision. Moreover , WP29, while recognizing the effort to create additional oversight mechanisms, considers those efforts not satisfactory: the new redress mechanisms, in practice, may prove to be too complex and difficult to use and, more specifically, the capability of the Ombudsperson mechanism to be truly independent from US governmental authorities is strongly questioned. The lack of clarity of the new framework is also stigmatized by the WP29 by calling for a glossary of terms to be included in the negotiated instruments, in order to ensure that the key data protection notions of the Privacy Shield will be defined and applied in a consistent way. Lastly, the WP29 points out, rightly, how the newly issued Privacy Shield documents already appear out-of-date, considering the approval and forthcoming enter into force of the EU data protection reform, which will bring important improvements on the level of data protection offered to individuals, not at all reflected in the Privacy Shield.

The adequacy of the Privacy Shield to address the issues raised after the CJEU decision invalidating Safe Harbour is hence, at least, arguable. The significant uncertainty created after the fall of Safe Harbour is not only far from being clarified but, possibly, worsened. The major concerns raised by the CJEU have not been adequately tackled, especially if one considers the absence of clear-cut undertakings of the US authorities on mass surveillance programs by security intelligence agencies. Regulatory costs on companies and governmental agencies will not therefore be balanced by stability, certainty and higher levels of fundamental rights protection, leaving everyone dissatisfied.

So, what’s next for Privacy Shield? Another advisory decision is awaited from Article 31 Committee after the second half of May. Then, different options are available but, basically, the implementation of Privacy Shield could take place with or without addressing WP29’s most important concerns. In any case, legal challenges before the CJEU, as well as claims brought to national data protection authorities, will always be open and much likely to happen, given the overall uncertainty characterizing transatlantic data flows: trust is, indeed, very far from being restored.